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Ideas and Opinions |17 February 2015

Clinical Trial Data Sharing: What Do We Do Now?

Steven N. Goodman, MD, MHS, PhD

Article, Author, and Disclosure Information
Author, Article, and Disclosure Information
This article was published online first at www.annals.org on 27 January 2015.
  • From Stanford University, Stanford, California.

    Acknowledgment: Dr. Goodman is a member of the committee that wrote the Institute of Medicine report.

    Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0021.

    Requests for Single Reprints: Steven N. Goodman, MD, MHS, PhD, Stanford University, 259 Campus Drive, HRP/Redwood Building T265, Stanford, CA 94305; e-mail, steve.goodman@stanford.edu.

    Author Contributions: Conception and design: S.N. Goodman.

    Drafting of the article: S.N. Goodman.

    Critical revision of the article for important intellectual content: S.N. Goodman.

    Final approval of the article: S.N. Goodman.

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Looking troubled amidst the hubbub of a successful election night, Robert Redford's title character in the 1972 movie The Candidate asks, “What do we do now?” We must ask the same question about clinical trial data sharing. Although the campaign for such sharing has effectively been won—with support expressed by government agencies, funders, research groups, journals, patient groups, and industry—data sharing is hardly routine (1). Maximizing its benefits and minimizing its risks remain a technical, procedural, and political challenge. This motivated the formation of the Institute of Medicine committee on Strategies for Responsible Sharing of Clinical Trial Data to outline principles and policies that should govern the sharing of data from clinical trials.
In this issue, Rosenblatt and colleagues (2) describe some of the risks of data sharing from the perspective of industry, including the dissemination of incorrect or misleading analyses and issues of patient confidentiality and consent. They express hope that the Institute of Medicine committee will address these risks, in concert with the benefits, in a balanced manner. The committee's report was released in January 2015 by members representing such diverse sectors as patient advocacy, academia, and industry (3). The risks and benefits outlined in the report include those described by Rosenblatt and colleagues.
The report's suggested timelines for sharing may get the most attention. The recommended maximum delay for data release is 6 months after primary publication for the data underlying a paper's analyses and 18 months after trial termination for...
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Goodman SN. Clinical Trial Data Sharing: What Do We Do Now?. Ann Intern Med. 2015;162:308–309. doi: https://doi.org/10.7326/M15-0021

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Published: Ann Intern Med. 2015;162(4):308-309.

DOI: 10.7326/M15-0021

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